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Making sense of surprise rejection of draft proposals.
In normal circumstances, journalists deliver tomorrow’s news today. But these are not normal circumstances in European drug regulation. Since 2019 the European Commission has been preparing changes to a once-in-a-generation revision of its comprehensive pharmaceutical rules. It was due to unveil its proposals for change next month, December, just in time for Christmas, so that the package could be slotted neatly into the EU’s legislative machinery for an early start on processing. However, things have not gone to plan.
A senior legislative scrutiny committee within the Commission has rejected the draft proposals—virtually on their way to the printers—and the process has come to a grinding halt. So instead of bringing you tomorrow’s news, this column can only offer information on yesterday’s news—a quick look at what the Commission officials had in mind—and offer some warnings about what this could mean for the future of European drug regulations.
The commission officials responsible for drafting the proposals have understandably been playing down this reversal. They have been insisting that the internal objections raised are merely technicalities—while being reticent about exactly how their draft has offended their superiors. And they have been offering reassurances that planning is still on for everything to go ahead “in the coming months.” But the coming months is proving to be as long as a piece of string. And the necessary rewrite to overcome the supposedly technical objections appears to be taking so long that the talk of publication has now stretched beyond January, beyond February, and into March—in other words, perhaps just in time for Easter.
The current rules that the revision is supposed to update go back as far as 2000, so an optimist could argue that a few more months here or there will not matter very much. But the optimists may be reckoning without the complex timetable for European legislation. Publishing the proposals is only a step in the formal legislative process, and a step that leads into a long and challenging corridor in which the formal proposals come in for lengthy evaluation and discussion in the European Parliament and in the Council, where member states’ ministers regularly meet. Typically, it takes one or maybe two years for the legislation to progress down this corridor while MEPs and ministers establish their own positions on the proposals, and a new law emerges into the light only after the two groups agree with one another on a compromise that they can both live with. And this legislation is hardly typical. It is complex, it is voluminous, and it is politically highly sensitive.
That is because the envisioned update of the legislation is going to be tackling issues as divisive as unmet medical need, affordability of medicines and patient access, and modernizing medicine development pathways. One of the most sensitive topics covered by the draft is the incentivization of innovation, particularly to restock the pipeline of antibacterials, and to promote treatments designed specifically for rare diseases and for children. This is a real hot potato in Europe, where advocates of research are in a continual face-off with critics alleging price-gouging by abusive monopolies. Controversially, the draft proposal toys with options for cutting back on the current EU incentives or for attaching onerous conditions to them, and offers calculations—admittedly uncertain—of the impact of each option, economically and in terms of product innovation. It is widely believed that questions over these calculations contributed to the rejection of the draft. The atmosphere is made all the more tense by widespread demands for drugmakers to come clean over how far public-funded research has benefited their products, and to cut their prices accordingly.
The discussions on the proposals—when they eventually appear—are likely, therefore, to be long and contentious. And a clock is ticking ominously. The European Parliament’s current five-year term ends in mid-2024, which makes the chances more remote of reaching even a preliminary agreement among MEPs every time the publication date of the proposals slips back. The next European Parliament—and its new intake of MEPs—is under no obligation to pick up unfinished business where its predecessor left off, so the proposals could just fade into oblivion, and an entirely new legislative procedure would be necessary.
That will be small comfort to the patients hoping for faster authorization of better medicines, or to healthcare payers anxious to cut back on excessive rewards for new drugs, or to drug firms—and investors—looking for greater clarity over the operating context in Europe. They will all be hoping, as 2022 turns into 2023, that yesterday is not going to be the pattern for tomorrow.
Reflector is Pharmaceutical Executive’s correspondent in Brussels.